Location:
Leverstock Green
Salary:
£35,000 per year
Recruiter:
WhatJobs
Job Hours:
Unknown
I am working in partnership with a leading healthcare manufacturer, who are a dynamic, and innovative company with a large portfolio of products. They specialise in the development of new products, using their unique technology platform. Due to growth in the business, they are looking for a Regulatory Affairs Associate to join the Regulatory Affairs Team.
The role will involve providing regulatory support to a number of regulatory projects, related to products and/or market entry. The role will include registrations, file updates, label changes, application of new or updated regulations (MDR, UDI, BPR, EPR etc.).
The Role:
* Planning, preparing and filing of global regulatory submissions for marketing authorisations, variations, supplements, amendments, promotional materials, labelling and other regulatory submissions as required by the business.
* Act as internal regulatory consultant for labelling/packaging, artwork for commercial portfolio across the regions.
* Carry out registrations, file updates, label changes, application of new or updated regulations (MDR, UDI, BPR, EPR etc.)
* Work with other Project Managers within the business to link regs requirements into other areas such as R&D, Quality and Marketing.
* Prioritise activities of each project individually, projects within the regs group and those across the wider business.
* Communicate project status within the Regs team and across the business.
* Coordination with external, regulatory stakeholders.
The Candidate:
* Ideally an honours degree, in a scientific or equivalent subject.
* Good background in Regulatory Affairs, ideally with experience within the Medical Devices, Pharmaceutical or Cosmetic industry.
* Self-motivated with the ability to deliver a high standard of work within agreed deadlines.
* Excellent interpersonal and organisational skills. Must be able to work well within a team and display strong problem-solving skills.
* Must work efficiently and be self-disciplined. Able to work well under pressure and to be able to identify the need to prioritise when required